Multilingual (Senior) Clinical Research Associate (s)CRA – sponsor-dedicated - Zollikon

☞ Covance Inc

View: 176

Update day: 26-03-2024

Location: Zollikon Zürich ZH

Category: R & D IT - Software

Industry: Biotechnology Hospital & Health Care Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

Job Description

Job Overview:

Multilingual (Senior) Clinical Research Associate (s)CRA – sponsor-dedicated

Location: Home Office, Switzerland

A formula for clinical innovation: Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60’000 employees advance life-changing medicines across a wide range of therapeutic areas. In this role, you will work directly with one of our renowned key sponsors and advance the development of innovative, life-changing medications for oncological therapies.

If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, this is the perfect opportunity.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, excellent career opportunities, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.

Sounds exciting? Then we are looking forward to meeting you!

As (Senior) Clinical Research Associate, You Typically Will
  • Own all aspects of site management as described in the project plans
  • Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study
  • Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible entries
  • Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports
  • Review progress of projects and initiate appropriate actions to achieve target objectives
  • Interact with internal work groups to evaluate needs, resources and timelines
  • Act as contact for clinical trial suppliers and other vendors as assigned
  • Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Independently perform CRF reviews
  • Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems
  • Assist with training, mentoring and development of new employees, e.g. co-monitoring
Education/Qualifications
  • Degree in a relevant field such as life sciences, health care (management), nursing, biology, chemistry, pharmacology, (veterinarian) medicine, oecotrophology etc.
  • In lieu of the above, a completed equivalent higher vocational education with an appropriately accredited institution (e.g. licensed study nurse, study coordinator...)
Experience
  • Proven experience in clinical research in a variety of therapeutic areas including oncology
  • Solid independent monitoring experience in Switzerland as (Senior / Lead) CRA
  • Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the Swiss regulatory authorities landscape
  • Working knowledge of Microsoft Word, Excel and PowerPoint
  • Effective time management and organizational skills and a keen attention to detail
  • Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
  • Business fluency in German and English is a must, working knowledge in French and / or Italian a definite plus
Remote

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Deadline: 10-05-2024

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